BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity of Chicago
About this trial
The purpose of this research study is to prospectively collect biospecimens, imaging, and clinical data from patients with penetrating brain injuries across high-volume PBI sites in the US (including UChicago). Biospecimens will undergo biomarker analysis - biomarker data specific to PBI is extremely limited, and could provide critical insight to outcome identification and clinical decision making.
This data will be used to build the first comprehensive PBI Data Commons, biorepository, and imaging repository which will create the infrastructure necessary to close critical knowledge gaps, advance biomarker discovery specific to PBI, and provide the foundation for future research aimed at improving prognostication and treatment for patients with this devastating injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Subjects aged 16 years and older
Injury Type/Evidence: Patients with a confirmed PBI as demonstrated by head imaging or physical exam (evidence of dural penetration by a projectile)
Timeframe: Patients must be enrolled within 8 hours of injury
Disqualifiers
Dead on Arrival (DOA): Patients who receive CPR with no return of pulse
Non-penetrating injury: Patients with head injuries that do not include dural penetration
Polytrauma: Patients with penetrating or blunt injuries to other parts of the body
Known or suspected pregnancy
Trial population
Subjects with confirmed PBI.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Blood Sample Collection
Other interventionSubjects with confirmed Penetrating Brain Injury (PBI) will be enrolled upon arrival to each site and have blood samples collected at five timepoints by nurses/phlebotomists/approved research personnel. As soon as possible after injury, preferably within 4 hours of injury, but must be obtained within 8 hours of injury.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Building the first PBI Data Commons, Biorepository, and Imaging Repository
The primary objective of this prospective study is to build the first comprehensive PBI Data Commons, Biorepository, and Imaging Repository. Clinical data, biospecimens, and imaging from subjects with PBI will be prospectively collected and analyzed across multiple sites, which will then be used to build these resources.
Time frame
3 monthsSecondary outcomes
1
Quantitative biomarker analysis using validated laboratory assays conducted at Orlando Health and Mayo Clinic Laboratories.
Biospecimens will undergo biomarker analysis. This will provide another critical layer of information in the repositories for future studies aiming to improve rapid detection, diagnosis, prognostication, and outcome for casualties with PBI.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: